Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 1) 2018 (Cth)
Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 1) 2018
I, David Weiss, First Assistant Secretary, Medical Benefits Division, Department of Health, make the following instrument.
Dated 27 June 2018
David Weiss
First Assistant Secretary, Medical Benefits Division, Department of Health
Contents
1 Name........................................................................................................................................ 1
2 Commencement........................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Schedules................................................................................................................................. 1
Schedule 1 —Amendments commencing on the day after registration 2
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 2
Schedule 2 —Amendments commencing on 1 December 2018 3
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 3
1 Name
This instrument is the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 1) 2018.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. Sections 1 to 4 and anything in this instrument not elsewhere covered by this table | The day after this instrument is registered. | |
| 2. Schedule 1 | The day after this instrument is registered. | |
| 3. Schedule 2 | 1 December 2018 | 1 December 2018 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in Column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 23DNA(1) of the Health Insurance Act 1973.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments commencing on the day after registration
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017
[1] Schedule 2 (at the end of the table)
Add:
| 21 | Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) | 2015 |
Schedule 2—Amendments commencing on 1 December 2018
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017
Section 5 (note to the section heading)
Repeal the note.
After subsection 5(1)
Insert:
Note: A number of expressions used in this instrument are defined in the Act, including the following:
· accredited pathology laboratory;
· approved pathology authority;
· approved pathology practitioner;
· medical practitioner;
· pathology service;
· pathology services table.
Subsection 5(2) (definition of accreditation materials)
Repeal the definition, substitute:
accreditation materials means each document mentioned in Schedule 1, published in the year mentioned for the document.
Subsection 5(2)
Insert:
designated person means a person who is designated in an application for approval under section 23DN of the Act as the person responsible for a premises’ compliance with relevant standards.
Subsection 5(2)
Insert:
group of pathology testing means a group of items in the pathology services table.
Subsection 5(2) (paragraph (b) of the definition of independent body)
Repeal the paragraph, substitute:
(b) any other organisation approved under subsection (3) by the Minister.
Subsection 5(2) (definition of NATA)
Omit “being the body recognised by the Commonwealth through a Memorandum of Understanding as the national body in Australia for laboratory accreditation”.
Subsection 5(2) (definition of relevant standards)
Omit “relevant requirements of these Principles including sections 17 and 18”, substitute “section 18”.
Subsection 5(2)
Insert:
scope of practice means the discipline and areas of testing in which a person has:
(a) been trained and successfully examined or assessed as competent by the relevant College, professional society, or credentialing body; and
(b) met current Continuing Professional Development and recency of practice requirements.
Subsection 5(2) (definition of scientist)
Repeal the definition.
Subsection 5(2) (definition of senior scientist)
Repeal the definition.
Subsection 5(3)
Omit “subsection (2)”, substitute “subsection (4)”.
Subsection 5(3)
Omit “category M laboratory”, substitute “category or categories of laboratory”.
[14] Paragraph 5(4)(a)
Omit “body is a suitable body”, substitute “organisation is a suitable organisation”.
Paragraph 5(4)(b)
Omit “this instrument”, substitute “these Principles”.
[16] Section 7 (at the end of the heading)
Insert “or special adviser”.
[17] Paragraph 7(3)(a)
After “accreditation action”, insert “, or by a special adviser in its assessment report”.
[18] At the end of subsection 7(3)
Add “or the special adviser, as appropriate”.
[19] Subsection 8(1)
After “independent body”, insert “or special adviser”.
[20] Paragraph 8(2)(a)
After “independent body”, insert “, or an assessment report of a special adviser”.
[21] At the end of paragraph 8(2)(b)
Omit “the independent body later varies the report or accreditation action”, substitute “the report or accreditation action is later varied”.
[22] Section 9 (at the end of the heading)
Insert “or special adviser”.
Paragraph 9(1)(e)
After “independent body”, insert “or by the special adviser”.
Paragraph 9(2)(a)
Repeal the paragraph, substitute:
(a) must state whether or not it has been established with a high level of confidence that the pathology services to be rendered or rendered at the premises subject to the report meet, and can be expected to continue to meet, the relevant standards; and
At the end of subsection 9(2)
Add:
; and (c) may state any other matter which the independent body or special adviser considers relevant.
Subsections 9(3) and 9(4)
Repeal the subsections.
Paragraph 10(1)(a)
After “independent body”, insert “or a special adviser”.
Paragraph 11(1)(b)
Omit “paragraph (1)(a)”, substitute “paragraph (a)”.
Subsection 12(1)
After “independent body”, insert “or special adviser”.
Subsection 17(1) (table)
Repeal the table, substitute:
| Item | Category | Criteria |
| 1 | Category GX (General) | Premises comprising a laboratory, or a number of co‑located laboratories, that: (a) is under the full-time onsite direction and control of a designated person, who is a pathologist; and (b) renders services in 1 or more groups of pathology testing under the full-time onsite supervision of a pathologist (whether or not the designated person) with the relevant scope of practice. |
| 2 | Category GY (General) | Premises comprising a laboratory, or a number of co‑located laboratories, that: (a) is related by an appropriate arrangement to a GX laboratory; and (b) is under the direction and control of the designated person of the related GX laboratory; and (c) renders services in 1 or more groups of pathology testing under the full‑time onsite supervision of a pathologist with the relevant scope of practice; whether or not the premises also renders services in 1 or more groups of pathology testing under the supervision of a pathologist with the relevant scope of practice who is situated in: (d) the related GX laboratory (whether or not the pathologist is the designated person); or (e) another GY laboratory that is related to that GX laboratory. |
| 3 | Category B (Branch) | Premises comprising a laboratory, or a number of co‑located laboratories, that: (a) is related by an appropriate arrangement to a GX laboratory or GY laboratory; and (b) is under the direction and control of the same designated person as the related laboratory; and (c) renders services in 1 or more groups of pathology testing under the supervision of: (i) a pathologist (whether or not the designated person) who is situated in the related GX laboratory (if any); or (ii) a pathologist who is situated in the related GY laboratory (if any). |
| 4 | Category M (Medical) | Premises comprising a laboratory that: (a) is under the full-time onsite direction, control and supervision of a designated person, who is a medical practitioner; and (b) renders a limited range of pathology testing only for the patients of a medical practice that: (i) is operated by, or employs, the designated person; and (ii) is co-located with the laboratory. |
| 5 | Category S (Specialised) | Either of the following: (a) premises comprising a laboratory that: (i) is under the full-time onsite direction, control and supervision of a designated person, who is: (A) a medical practitioner with specialised scope of practice; and (B) not a pathologist; and (ii) renders a limited range of pathology testing: (A) for a target patient population or of a specialised nature; and (B) that is restricted to the field of pathology testing directly related to the scope of practice of the designated person; (b) premises comprising a laboratory that: (i) operates as a branch of a laboratory which meets the criteria in paragraph (a); and (ii) is under the direction, control and supervision of the designated person of that laboratory. |
Subsection 17(2)
Repeal the subsection, substitute:
(2) In the table in subsection (1), appropriate arrangement means a written arrangement that includes provision for the direction, control and supervision of the relevant laboratory.
Section 18
Repeal the section, substitute:
18 Standards of direction, control and supervision of premises required
(1) Premises must be under the direction, control and supervision of a designated person, who:
(a) possesses appropriate qualification; and
(b) is competent; and
(c) has relevant scope of practice;
to fulfil their obligations under this section.
(2) The designated person is responsible for premises’ compliance with relevant standards.
(3) Without limiting subsection (2), the designated person is responsible for compliance with the standards of direction, control and supervision that apply to the relevant category of laboratory under the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018), including in relation to:
(a) the clinical governance of the laboratory; and
(b) oversight and management of the laboratory’s staff and processes to ensure ethical patient care and the provision of accurate and timely test results.
(4) The designated person may only supervise pathology testing within his or her scope of practice.
(5) The responsibilities of the designated person for premises under this section may be delegated, but only in accordance with the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2018).
Note: The Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2017) is listed in Schedule 1.
[33] Schedules 1 and 2
Repeal the Schedules, substitute:
Schedule 1—Accreditation materials
Note: See definition of accreditation materials in subsection 5(2).
NPAAC materials
| Item | Material | Publication year |
| 1 | Requirements for the Estimation of Measurement Uncertainty | 2007 |
| 2 | Guidelines for Approved Pathology Collection Centres (Requirements for Medical Pathology Specimen Collection) (Third Edition 2013) | 2013 |
| 3 | Requirements for Cytogenetic Testing (Third Edition 2013) | 2013 |
| 4 | Requirements for Information Communication (Third Edition 2013) | 2013 |
| 5 | Requirements for Laboratory Testing for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) (Third Edition 2013) | 2013 |
| 6 | Requirements for Medical Testing of Human Nucleic Acids (Second Edition 2013) | 2013 |
| 7 | Requirements for Medical Testing of Microbial Nucleic Acids (Second Edition 2013) | 2013 |
| 8 | Requirements for the Facilities and Operation of Mortuaries (Third Edition 2013) | 2013 |
| 9 | Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (Fourth Edition 2013) | 2013 |
| 10 | Requirements for the Performance of Anatomical Pathology Cut‑Up (Fourth Edition 2013) | 2013 |
| 11 | Performance Measures for Australian Laboratories Reporting Cervical Cytology (Third Edition 2015) | 2015 |
| 12 | Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Fifth Edition 2015) | 2015 |
| 13 | Requirements for Human Medical Genome Testing Utilising Massively Parallel Sequencing Technologies (First Edition 2017) | 2017 |
| 14 | Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017) | 2017 |
| 15 | Requirements for Semen Analysis (First Edition 2017) | 2017 |
| 16 | Requirements for Transfusion Laboratory Practice (Third Edition 2017) | 2017 |
| 17 | Requirements for Medical Pathology Services (Second Edition 2017) | 2018 |
| 18 | Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2017) | 2018 |
| 19 | Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fourth Edition 2017) | 2018 |
| 20 | Requirements for the Development and Use of In-House In Vitro Diagnostic Devices (Fourth Edition 2017) | 2018 |
| 21 | Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2017) | 2018 |
Note The documents mentioned could in 2018 be viewed on NPAAC’s website, maintained by the Department of Health (
0
0
0